Is it possible that a growing number of lawsuits against stem cell clinics could freeze or reverse the growth of the clinic industry that sells unapproved medical therapies? If so, then it would achieve what so far the FDA hasn’t.

Both in the public domain and through the grape-vine I’m hearing that there are a growing number of attorneys zooming in on stem cell clinics.

Screenshot from The Lung Institute website

Here in California a law firm is advertising a potential class action suit against one or more stem cell clinics. Details remain sketchy so far.

Now late last week, The Tampa Bay Times reportedthe filing of a class action suit by Tammy Rivero against the stem cell clinic The Lung Institute (HT to Alexey Bersenev):

“In 2014, Rivero took out a home equity loan to pay $7,500 and traveled from her western North Carolina home to Florida to undergo stem-cell therapy at the Lung Institute in Tampa. The institute claimed she would see results in a matter of weeks, according to a lawsuit Rivero filed last week.

Instead, according to the suit, she got worse. Now Rivero, 58, is the first of what her attorney says are dozens of former patients seeking class-action status in a legal action against the institute.”

“It’s one thing for folks that have an incurable disease to try experimental treatments,” said Rivero’s attorney, Ben Vinson Jr. of Tampa. “But it’s another when the person offering the treatment knows it doesn’t work.”

The Lung Institute was quoted as indicating that they believe the current case has no merit:

“Speaking for the institute, Lynne Flaherty Margnelli, executive vice president of Regenerative Medicine Solutions, said in a statement to the Tampa Bay Times:“Lung Institute prides itself on putting patient care first and always operates with the patients’ best interests in mind. We do not believe the case has any merit and we look forward to resolving this matter.”

Of course, in cases like this the clinics are simply alleged to have done certain things and are innocent unless proven otherwise. The cases do shed interesting light on the stem cell clinic industry though.

The Times also included this interesting information:

“A 2015 Times story said there is little evidence that the institute’s treatment works for patients with incurable lung conditions such as chronic obstructive pulmonary disease, or COPD.

Dr. Burton Feinerman, who was medical director at the Lung Institute when the Times story ran, said then that the American medical establishment is too slow to embrace developments.”

As a stem cell biologist myself, I’m not aware of solid evidence that stem cells of this kind could effectively and safely treat lung disease. To me this kind of use also sounds like it would likely be non-homologous use, and if so that would make the stem cells a biological drug seemingly requiring pre-approval by the FDA.

More generally, stem cell clinics are thought to generate large amounts of money and this issue came up in the Times piece as well:

“According to the suit, the cost of the procedures ranged from $5,000 to $12,000. The suit claims the institute, which occupies a fourth floor of a downtown Tampa office building, brings in at least $2 million a month.”

This financial claim may or may not be accurate, but that would add up to $24 million per year for just one stem cell clinic out of more than 500 in the U.S. today.Also of interest is if you figure the average cost based on this quote might be around $8K-$10K, then if these numbers are accurate that means that this clinic has around 200 stem cell customers a month. That sounds awfully high.

23 Comments

There is no way that this clinic or any other clinic doing stem cell procedures is taking in 2 million dollars a month. I’ve been to dozens of clinics in dozens of countries and even the most upscale high end clinics are not doing that kind of business.

I missed David B’s guest post to comment in time, but this was telling:
“However, I was surprised by the reaction of the patients in the audience as the majority echoed Ms. Myers displeasure and were applauding as I was leaving.”

Apparently neither you nor I are in the medical professions, and you are mistaken. You would be amazed at the results when the stem-cells in that small vial of blood are treated in a lab and enhanced and concentrated. And they are safe for you to use because they are your own cells, so there is no risk of your body rejecting them.

It seems important to me to know what you know, and to know what you don’t know… and to know the difference.

Hi Richard, as a clinical immunologist, perhaps I can clarify. You say, “they are safe because they are your own cells, there is no risk of your body rejecting them.”

I’m afraid that’s a widespread misconception, especially nowadays, in the autologous stem cell field. When cells are removed from the body, they begin to express a number of novel factors that may be recognized as foreign when readministered. The immune response can be innate or acquired and have both allergic and/or autoimmune character.

Such changes are more likely to occur if cells are manipulated or ” enhanced and concentrated” as you put it. In this scenario, additional foreign factors in the media can act as adjuvants and generate an immunogen, which then strongly activates the immune system to fight the cells.

I considered going to the Lung Institute Clinic when I was diagnosed with Pulmonary Fibrosis after suffering from its effect for 2 or 3 years prior to diagnosis. My prognosis was not good and was told in about 3 years I would need a Lung Transplant. I searched for many answers to beat this disease and I too was hopeless and nearly ended up going here to getting this done. I attended a few web seminars and was about to drop the $10,000. I even sent them my information and spoke to their staff in the front office. The only reason I think I didn’t rush into was because I would have to take off of work and travel to Tampa and also I didn’t want my regular doctors to know I was considering this so I never asked them to transfer my medical information to the Lung Institute.

During the time pondering, I was able to do more research and found it quite odd that the only success stories from these treatments were advertised by the clinic themselves. I searched the web for weeks, possibly even months and I couldn’t find one definitive positive story that was independent from the clinic. Another thing that raised a red flag was Dr. Feinerman’s almost defensive nature when people who attended his live seminar’s asked valid questions about the effectiveness and risks for the treatment. He even went so far as to call traditional doctors that advised against this procedure as “idiots”; major red flag.

As time went by I realized there was no “secret” way to beat the disease and if there were teaching hospitals would be all over it and at the minimum conducting clinical trials. I finally got to a point where I was able to accept that I would either eventually die, or get a transplant. Luckily for me it was the later as i received two healthy lungs in 2015.

I truly understand the desperation of people looking for hope when nothing else has worked because I have been there and have lived to tell about it. I seriously hope this clinic and those like it aren’t selling false hope to desperate people who just want to live a normal life.

The Stem Cell treatment is quite fast, in the clinic ,they take your blood, and you wait in a room breathing Oxygen with the nasal tubing, then 20 minutes later they come back in and give your blood back by IV,and a booster injection, this happens for three days. then you travel back home. Call a place in Dunedin, Fla ,they send you a vaporizer and a medicine called Glutathion, and you breath that in for 30 days and it’s automatically reordered for you every 30 days,until you get better or quit the treatment plan….SO the treatment can be either $5,500 to $12,000….depends if you have the blood taken from the arm, belly fat area ,or bone marrow,which is the most expensive procedure, but it takes the same amount of time to spin the blood in the centrifuge machine…SO for me the treatment was a waste of $6,000.00 cause there wasn’t long enough time to separate the stem cells from the blood to be given back by IV the same day…

my son in law is about to be put on the lung transplant list. How has your life been since. could you private email me at [email protected]. Have been trying to investigate the Lung Institute. Your comments are most helpful. Gwen

Dr. Adam,
I’m a 76 yr old man, was diagnosed with copd 12 yrs ago. Now I’m at the 4th stage..We watched the testimonies on the lung institute web site & the ones we watched said it helped them, and there lung function improved and there doing better, so after seeing that I was interested in having it done..I don’t know what to do now, after reading some people saying it was a waste of there money..Any advice would be very appreciated…

I was diagnosed with IPF back in 2014, and the only reason I’m alive today is because of a bilateral transplant. I too did extended research on this facility and procedure. I’ve been in your position and I was almost to the point where I was going to drop the $7500 – $12500 for the procedure.

Despite all the red flags going off, I tried to ignore them holding out hope that this was the magical cure to solve all my breathing problems. If I wasn’t so turned off by the Dr’s attitude towards traditional doctors, who knows I may have done it.

Based on what I’ve read, I don’t think the procedure would hurt you other than the risk of infection which is always the case with medical procedures, but at the same time, I don’t think it would help either.

There are just too many red flags for me to be comfortable with anyone doing it unless they have that kind of money to throw away in case it doesn’t.

I’m sorry to hear about your lung condition. Medicine has advanced quite a lot, but still not to the point where people don’t have to worry about lung diseases like COPD, asthma, and IPF. I am hoping for the best for you and that you make the right decision.

I had the originally treatment for 8,500 A booster for 5,500. than the lung institute offered buy one get one free now its time for the free one and they don’t answer their phone I’m not sure about the first treatment but I got pneumonia after the second ,so I’m really upset